BIOTRONIK Evia DR, Technical Manual

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22 Evia Technical Manual
Table 1: Adverse Events Reported in > 1 Patient
Category # pts
(n-273)
% of
patients
# of
AEs
AE/pt-
mo
(n-1418)
Pt-mos
between
AEs
Observations
†
(total)
79
*
28.9% 86 0.0606 16
Atrial Loss of
Sensing 10 3.7% 10 0.0071 142
Atrial Loss of
Capture 8 2.9% 8 0.0056 177
Pacemaker
Mediated
Tachycardia 11 4.0% 12 0.0085 118
Premature AV
Stimulation 4 1.5% 4 0.0028 355
Arrhythmias 34 12.5% 36 0.0254 39
Muscle/Diaphragm
atic Stimulation 3 1.1% 3 0.0021 473
Unexplained
Syncope 3 1.1% 3 0.0021 473
Complications
‡
(total)
14
*
5.1% 14 0.0099 101
Atrial Lead
Dislodgment 6 2.2% 6 0.0042 236
Ventricular Lead
Dislodgment 4 1.5% 4 0.0028 355
All Dromos DR Patients (N-273), Number and % of Patients, Events/Patient Mo.,
and Pt-Mos. between Events
†
Observations are adverse events, which are correctable by non-invasive
measures, e.g., reprogramming.
*
Not included in the Table are 6 observations and 4 complications each having
only one occurrence.
‡
Complications are adverse events requiring invasive measures to correct,
e.g., surgical intervention.